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Biospecimen Storage: The Overlooked Risk That Derails Trials - And How to Fix It
Sometimes, the most expensive mistakes hide in plain sight - or, more accurately, out of sight, behind a freezer door. Ask a study team why biospecimens fail, and you’ll hear about a collection technique or a courier who missed a pickup. Fair. But the quiet failure mode is storage. It’s distributed, assumed, and rarely engineered with the same rigor we give randomization or endpoint analysis. Six months later, storage comes back as assay variability, re‑runs, CAPAs, and a tim
Elena Sinclair
Nov 148 min read


The Dirty Secrets of Biospecimen Shipment.
Biospecimen logistics in clinical trials are often an afterthought—until something goes wrong. From customs delays to misrouted samples, this post explores the hidden chaos of sample shipping and how to build a resilient, operations-first strategy that ensures sample integrity, even under pressure.
Elena Sinclair
Jun 177 min read


When Science Leaves the Lab: The Real-World Risks of Biospecimen Processing
When biospecimen processing fails, it’s not usually the science—it’s the gap between protocol and practice. From centrifuge errors to customs delays, silent pre-analytical variables sabotage the biospecimen lifecycle long before the assay begins. If we don’t build operational readiness into our protocols, even the most promising biomarker study can unravel before the data is even analyzed.
Elena Sinclair
Jun 1010 min read


The Hidden Risks in Biospecimen Collection—and How to Eliminate Them
Biospecimen collection may seem routine, but in clinical trials, even small missteps—like a misunderstood morning urine sample—can compromise data integrity. This article explores how overlooked details in biospecimen collection can derail clinical trials and offers strategic solutions to protect your data from the first draw to final analysis.
Elena Sinclair
Jun 612 min read


What I Learned About Biospecimen Planning From a Loose Saddle and a Smug Horse
A loose saddle, a smug horse, and an unexpected lesson in clinical trial design. This article explores how poor biospecimen planning can derail even the best biomarker strategies — and why it must be treated as a core component of trial quality, not a CRO afterthought. From patient safety to regulatory compliance, discover the 10 domains every study must get right to stay on track and upright.
Elena Sinclair
May 266 min read


Making a Biomarker Strategy in Clinical Trial Operational. To Start With
Discover how operationalizing biomarker strategies can transform clinical trial outcomes. From biospecimen logistics to assay readiness, this article explores the critical role of biospecimen professionals in precision medicine. Learn how proactive planning reduces screen failures, accelerates timelines, and improves trial success rates. If you're designing biomarker-driven trials, this is your blueprint for efficient, scalable, and regulation-ready execution.
Elena Sinclair
May 209 min read


Lost in the Lab Manual: Why Clinical Trials Need a Digital Makeover
Outdated lab manuals are sabotaging clinical trials. It’s time to ditch the PDF tomes and go digital—real-time, role-based, and smart.
Elena Sinclair
Apr 94 min read


We’ve Been Looking at Biospecimen Lifecycle All Wrong—Here’s Why That Needs to Change
Rethink the biospecimen lifecycle: plan early, optimize storage, and maximize research impact for precision medicine and biomarker discovery
Elena Sinclair
Mar 178 min read


Don’t Wear a Swimsuit to a Cocktail Party: Biospecimen Operations Career Ladder for Biotech
There is such a thing as a career ladder for biospecimen professionals Imagine receiving a party invitation in the mail - it's beautiful,...
Elena Sinclair
Feb 195 min read


Biospecimen Masters: The Key Skills of Top Biospecimen Professionals
Biospecimen management is a stand-alone, highly specialized role that requires the right expertise In our last post , we explored the...
Elena Sinclair
Feb 124 min read


Do Sponsors Care About Clinical Trial Participants?
Traditional biospecimen collection in clinical trials is outdated and burdensome. Explore why change is needed and how patient-centered inn
Elena Sinclair
Jan 305 min read


Why Every Biotech Deserves a Biospecimen Manager
Biosample management isn't just moving samples; it's a critical, specialized function that ensures trial success.
Elena Sinclair
Jan 215 min read
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